AccessGUDID - DEVICE: ManaMed (00810113680859)

GUDID

Device Identifier (DI) Information

Brand Name: ManaMed
Version or Model: Kahuna Brace
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KB001
Company Name: Manamed, Inc.

Primary DI Number: 00810113680859
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084042331 *Terms of Use

Device Description: The Kahuna Brace provides support for shoulder surgeries in a universal multiple configuration brace. Suitable for all shoulder surgeries as well as conservative care of shoulder injuries. The Kahuna Brace is your new go to shoulder brace for all your clinical needs. Sized universal Low-profile design True Airplane or Gunslinger alignment Two step application Multiple abduction angles Extreme external rotation

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
12101	Shoulder immobilizer/orthosis, reusable	A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQQ	Joint, Shoulder, External Limb Component

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0f38fa26-7f99-4f27-995c-edc39338c65d
Public Version Date: July 11, 2024
Public Version Number: 2
DI Record Publish Date: June 20, 2022